Shorter regulatory pathway confirmed by FDA and potential for Schedule 3 classification
ORLEANS, Ontario, Sept. 27, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its dronabinol AdVersa™ mucoadhesive product, PPP002. The purpose of the meeting was to obtain confirmation of the eligibility of PPP002 for the 505(b)(2) NDA and the requirements for marketing approval.
The FDA confirmed the eligibility of the 505(b)(2) regulatory pathway for the product PPP002 and that the efficacy and systemic safety would be supported by the corporation’s proposed comparative bioavailability study and if successful Tetra could apply for FDA approval in Q1 2019, for Chemotherapy Induced Nausea and Vomiting as well as Anorexia associated with Weight Loss in Patients with AIDS. The FDA also provided feedback on the local safety requirements and the evaluation of the abuse potential of PPP002 for obtaining a Schedule III controlled substance classification.
“We are very pleased with the outcome of yesterday’s meeting with the U.S. FDA,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “The FDA confirmed the shorter regulatory path to the market that Tetra had promised shareholders. In addition, the FDA also provided clear guidance on the safety and drug abuse data requirements for the new drug application. With this confirmation and guidance, Tetra can now complete the execution of the clinical program for PPP002 and, if successful, anticipates submitting a New Drug Application to commercialize PPP002 in Q1 2019.”
According to the International Agency for Research on Cancer1, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US$1.88 bn by 2020, an increase from its 2013 valuation of US$1.28 bn. Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that AdVersa™ could gain significant market share within three (3) years of its launch in the USA.
Reducing Opioid Use
The opioid crisis is serious and growing throughout North America. Tetra’s rich cannabinoid-derived product pipeline has the potential to play a significant role in opioid sparing, thus addressing a societal issue of critical proportion. Tetra expects to undertake a Phase II clinical trial using PPP002 up against an opioid to treat chronic pain.
A bout Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of PPP002, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.
Executive Vice-President Corporate Development and Licensing
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Source: Tetra Bio-Pharma Inc